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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022369

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NDA 022369 describes LATISSE, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LATISSE profile page.

The generic ingredient in LATISSE is bimatoprost. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.

Summary for 022369

Tradename:1
Applicant:1
Ingredient:1
Patents:11
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 022369

Ingredient-typeProstaglandins

Medical Subject Heading (MeSH) Categories for 022369

Suppliers and Packaging for NDA: 022369

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369 NDA Allergan, Inc. 0023-3616 0023-3616-04 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-04) > 3 mL in 1 BOTTLE, DROPPER
LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369 NDA Allergan, Inc. 0023-3616 0023-3616-03 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-03) > 3 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;TOPICALStrength0.03%
Approval Date:Dec 24, 2008TE:ATRLD:Yes
Regulatory Exclusivity Expiration:Sep 4, 2017
Regulatory Exclusivity Use:INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING USE OF LATISSE IN PATIENTS WHO WERE POST-CHEMOTHERAPY OR HAD ALOPECIA AREATA, AND ADOLESCENTS WHO HAD HYPERTRICHOSIS WITH NO ASSOCIATED MEDICAL CONDITION
Patent:► SubscribePatent Expiration:Aug 25, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS
Patent:► SubscribePatent Expiration:May 25, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF INCREASING HAIR GROWTH

Expired Orange Book Patents for NDA: 022369

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AllerganLATISSEbimatoprostSOLUTION/DROPS;TOPICAL022369-001Dec 24, 2008► Subscribe► Subscribe
AllerganLATISSEbimatoprostSOLUTION/DROPS;TOPICAL022369-001Dec 24, 2008► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Teva
McKesson
Deloitte
Chinese Patent Office
Chubb
Healthtrust
Dow
Express Scripts

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